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Z-1565-2016 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-1565-2016 was initiated by Baxter Healthcare Corp. on February 16, 2016 and is designated Class II. Reason for recall: Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total rec… The recall status is terminated (terminated December 23, 2016). Affected quantity: 10 units.

Recall Details

Product Type
Devices
Report Date
May 4, 2016
Initiation Date
February 16, 2016
Termination Date
December 23, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 units

Product Description

Automated peritoneal dialysis (APD) cycler

Reason for Recall

Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot

Distribution Pattern

US Consignee: NY ***Foreign Consignee: Ecuador

Code Information

N/A

Other recalls by Baxter Healthcare Corp.

  • Z-3133-2017 Class II — Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 (September 1, 2017)
  • Z-0370-2017 Class II — GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 1106 (October 12, 2016)
  • Z-0671-2017 Class II — Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infus (September 28, 2016)
  • Z-0672-2017 Class II — V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spec (September 28, 2016)
  • Z-0670-2017 Class II — sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum In (September 28, 2016)
  • Z-2533-2016 Class II — Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product (June 24, 2016)
  • Z-2049-2016 Class II — PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy (May 23, 2016)
  • Z-1839-2016 Class II — COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular re (May 12, 2016)
  • Z-1840-2016 Class II — COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular re (May 12, 2016)
  • Z-1838-2016 Class II — COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular rec (May 12, 2016)

FDA data resources